- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical... Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data and Identify and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset ... dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help ... including experience in one or more key functions (eg, clinical research, clinical operations, data management, biostatistics, project management) required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …seeks to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services (eg, CRO, ... Biomarker, CDx, Clinical Supplies, central labs); Must have strong problem-solving skills...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... and ensuring adoption for Generative AI solutions process, from data acquisition and pre-processing to training and deployment across various departments of Daiichi… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing...plans, and addressing all regulatory, drug and patient safety, data , CMC, IP, patient selection, market acesss and and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary The Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports process improvement project ... best practices. Provides key support for process improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Bristol Myers Squibb (Madison, NJ)
- …from study start to database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership role considered essential ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description** Clinical Data Management k ey focus is to ensure … more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Clinical Data and Reporting Standards (CDARS) proactively ... Design Domains + Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer's Guides for both FDA and PMDA submissions. + Consult on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …device, pharmaceutical company, or similar environment (eg, CRO) required + Experience with clinical data standards required Daiichi Sankyo, Inc. is an equal ... Daiichi Sankyo and regulatory requirements. + Functional Expertise: + Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures integrity and interpretation of study data of a clinical development program. The Sr. Manager leads in a matrix environment as part ... The Senior Manager , Hematology, Clinical Scientist leads in...critical risks and mitigations + Promotes consistent first line medical/ clinical data review techniques and conventions across… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager reports to the Director, Clinical ... We are seeking a **Senior Manager , Clinical Sciences** to lead in... data analysis + Promoting consistent first line medical/ clinical data review techniques and conventions across… more
- Stryker (Mahwah, NJ)
- …our award-winning organization by visiting stryker.com Stryker is seeking to hire a ** Clinical Study Manager ** to support Joint Replacement Clinical Trials. ... launched with precision. **What you will do** As the ** Clinical Study Manager (CSM),** you will manage...registries and large databases + Work in compliance with clinical process, regulations and data management +… more
